Academic Medical Centers Face Multiple Challenges For Conducting
Medical Research

NEW YORK - To maintain their effectiveness for conducting medical
research, academic medical centers must face critical issues such as
constrained funding sources, scientific integrity, recruiting
physician-scientists, and the increasing costs of research, according
to an article in the September 21 issue of JAMA, a theme issue on
medical research.

Lead author Jordan J. Cohen, M.D., of the Association of American
Medical Colleges (AAMC), Washington, D.C., presented the article today
at a JAMA media briefing on medical research.

Dr. Cohen and co-author Elisa K. Siegel, A.B., of the AAMC, examined
the status of medical research at academic medical centers.

"The present era offers more promise for progress in medical research
than ever before. Contemporary science has deciphered the human genome,
discovered some of the potential of stem cells, and unleashed the power
of information technologies. Any one of these three historic scientific
achievements would have the potential to effect a fundamental
transformation in medicine; their confluence has created unprecedented
opportunity for spectacular breakthroughs in human health."

The authors write that despite this promise for progress, many
challenges await medical research:

·The need to manage high (and often unreasonable) public expectations
for lifesaving discoveries.

·The need to maintain public trust despite the suspicions aroused by
financial conflicts of interest.

·The need to sustain the cultural norms of academe while partnering
with industry to promote technology transfer.

·The obstacles to recruiting and retaining physician-scientists to
pursue translational research.

·The widening gap between the costs of research and available funding
sources.

·The unfunded mandates with which investigators and institutions must
comply.

·The need to transform an academic reward structure built to encourage
individual scientists to pursue their own ideas into one that fosters
teams of collaborating investigators to pursue "big science".

Promoting Public Understanding

"Having raised expectations with tantalizing promises of scientific
breakthroughs, the research community has an obligation to help the
public understand the process of medical research and the often uneven
and incremental pace of progress that characterizes most medical
discoveries," the authors write. "Academic medical centers, as sources
of much of the advances in medicine, have a special role to play in
managing the public's expectations and can do so by ensuring that
public communications about their research developments are tempered
with realistic assessments of their practical impact."

Managing Financial Conflicts of Interest

Financial conflicts of interest on the part of investigators and their
institutions have the potential both to undermine the integrity of the
scientific process and to compromise the safe conduct of human
research. "According to a 2004 AAMC survey, the academic medicine
community has made substantial progress in moving beyond the minimum
requirements prescribed by federal regulations to strengthen the
safeguards against conflicts of interest in human research. However,
this survey also revealed that the academic medicine community still
has more work to do to establish a uniformly robust set of policies and
procedures. . Sustaining public trust in the medical research
enterprise will, at minimum, require continued efforts to identify and
address ways to improve the protection of human research subjects and
to buttress the management of financial conflicts of interest."

Maintaining Academic Values

According to the authors, examples of the potentially damaging effects
of academic-industry relationships include real or perceived pressures
to relax scientific standards, inducements to become advocates (or
shills) for industry, suppression of nonoptimal research results,
incomplete or misleading descriptions and interpretations of trial
results, and premature termination of clinical trials. "Academic
medical centers and their industry partners must be willing to adopt
more uniform, more robust, and more transparent standards governing
their relationships if the mutual benefits of those relationships are
to be sustained."

Sustaining Research Funding

In recent years, the growth of federal funding for medical research has
decreased, with the NIH's budget growing by less than the rate of
inflation. Compounding this restrictive fiscal climate are the
increasing costs of modern science and of complying with the
ever-increasing burden of government regulations.

"The White House Office of Science and Technology Policy and Office of
Management and Budget have undertaken a cross-agency initiative to
identify more efficient business models and to streamline agency
requirements for federally sponsored research, giving rise to some hope
that the federal government will at least partially restore the balance
of responsibility that formerly characterized the historic
federal-academic partnership in the country's research enterprise. If
some relief is not forthcoming, some institutions may find it
impossible to sustain their sponsored research programs."

"Academic medical centers face many difficult challenges in pursuing
their research mission, and the interconnectedness of those challenges
magnifies the difficulty. The ability to nurture and sustain a vibrant
clinical research workforce in the future is heavily dependent on the
ability to shift the academic culture and reward system away from the
traditional paradigm focused on the individual investigator in favor of
one that is more collaborative, team-based, and interdisciplinary," the
authors write.

"The ability to sustain financial support for medical research in the
face of constrained federal and state budgets is heavily dependent on
managing unrealistic public expectations and on maintaining public
trust. The ability to benefit optimally from the growing relationships
with industry is heavily dependent on remaining true to fundamental
academic values, including the safety of human subjects research, the
integrity of the scientific process, and the free exchange of research
results. The degree to which medical schools and teaching hospitals are
successful in meeting these challenges will determine the degree to
which the historic promise of modern medical science will be realized,"
the authors conclude.

(JAMA. 2005; 294:1367 - 1372. www.jamamedia.org.)



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